ABSTRACT
Real World Evidence (RWE) is transforming oncology by integrating insights from randomized clinical trials (RCTs) with real-world data, enhancing personalized care, optimizing treatments, and informing clinical and regulatory decisions. This expert opinion, based on a multidisciplinary Italian project, demonstrates RWE’s ability to address gaps in RCTs, especially for complex or underrepresented populations, using case studies from the Fondazione Ricerca e Salute (ReS) healthcare database.
While RWE shows transformative potential, challenges remain in data quality, accessibility, and regulatory integration. Experts emphasize standardizing data collection and harmonizing methodologies across healthcare systems to ensure actionable insights. RWE is also crucial
for pricing, reimbursement, and regulatory approvals, particularly in cases where large-scale trials are infeasible or raise ethical concerns.
The integration of artificial intelligence tools is highlighted as essential for advancing data processing and analysis, enabling RWE to provide more nuanced insights. Collaboration among healthcare providers, researchers, and policymakers is critical to harness RWE’s full potential. By addressing these challenges, RWE can improve patient outcomes, streamline resource allocation, and enhance decision-making in oncology, driving progress toward more efficient and personalized cancer care.

IMPACT STATEMENT
This study highlights how real-world evidence complements clinical trials, advancing precision oncology and supporting regulatory and healthcare decision-making for improved patient outcomes.

Supplementary Material
Fondazione Ricerca e Salute (ReS) grants the right to consult the Supplementary Material.